Isolator line with LAF hood for material input Blood Management and Mesenchymal Stem Cells processing

A case study of Comecer ATMP solutions

Isolator line with LAF hood for material input

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Scope

Production line for Cord Blood Unit Management and Mesenchymal Stem Cells processing in a privately held Cord Blood Bank

Main Features

The line is composed of 3 isolators, with flexible material insertion (direct through LAF and with VPHP sterilization), multiple processing options, bidirectional working options, integrated instrumentation (3 incubators, 2 refrigerators, 2 centrifuges).

Customer Challenge

As a private laboratory for the production of Advanced Therapies coordinated with the umbilical cord blood bank, SSCB needed to enlarge their facility. The SSCB process involves the material collection, pre-processing, and final processing. The new equipment is needed for processing perinatal adnexa and adipose tissue stem cells.

Performance Requirements

  • Work with a closed system
  • Minimize cross-contamination risks
  • Preserve HVAC system already in place
  • Comply with ATMP regulations such as GMP quality standards and national transplant regulations
  • Allow for future lab relocations

Solution Highlights

Comecer designed and manufactured three customized a Modular Cell Culture Isolators (MCCI). The systems allow different methods for material input and bidirectional flows from a common entrance point. This allows them to simultaneously work on different items in different environments, making the most of common areas.

This new equipment is in operation since November 2020.

 

Locatie: Vacallo

Categorie: ATMP

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